Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea
Phase 3, Placebo Controlled, Randomized, Double-blinded, Nonsteroidal Antiinflammatory Drug add-on Clinical Trial of Mono-phase Low Dose Oral Contraceptive Pill for Treatment of Primary Dysmenorrhea.
1 other identifier
interventional
115
0 countries
N/A
Brief Summary
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2008
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 29, 2008
CompletedStudy Start
First participant enrolled
September 1, 2008
CompletedFirst Posted
Study publicly available on registry
September 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2009
CompletedResults Posted
Study results publicly available
June 13, 2014
CompletedMarch 6, 2025
February 1, 2025
1 year
August 29, 2008
April 8, 2014
February 18, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Patient Response to Treatment for Primary Dysmenorrhea, as Evaluated by Difference of Total Dysmenorrhea Score (Baseline/Pretreatment-End of Treatment)
The detail of dysmenorrhea score that was used in this study is the following. These subscales summed for a total dysmenorrhea score (minimum 0 to maximum 6). Pain score None 0 : None Mild 1 : There are some troubles for work Moderate 2 : Needing to rest in bed and/or affecting work Severe 3 : Morre than 1 day in bed and not possible to work Drug score (during a menstrual period) None 0 : None Mild 1 : taking analgesics for 1 days Moderate 2 : taking analgesics for 2 days Severe 3 : taking analgesics more than 3 days
16weeks
Secondary Outcomes (1)
Difference in the VAS of Primary Dysmenorrhea (Baseline/Pretreatment-dnd of Treatment)
16weeks
Study Arms (2)
IKH-01
EXPERIMENTALethinyl estradiol 0.035mg and norethisterone 1mg
Placebo
PLACEBO COMPARATORPlacebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Interventions
Eligibility Criteria
You may qualify if:
- primary dysmenorrhea
You may not qualify if:
- severe hepatopathy
- pregnant woman
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Nobelpharmalead
Related Publications (1)
Harada T, Momoeda M, Terakawa N, Taketani Y, Hoshiai H. Evaluation of a low-dose oral contraceptive pill for primary dysmenorrhea: a placebo-controlled, double-blind, randomized trial. Fertil Steril. 2011 May;95(6):1928-31. doi: 10.1016/j.fertnstert.2011.02.045. Epub 2011 Mar 21.
PMID: 21420678RESULT
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Department director of clinical development department 1
- Organization
- Nobelpharma
Study Officials
- STUDY DIRECTOR
Naoki Terakawa, M.D.,Ph.D.
Nissay Hospital,Osaka,Japan
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 29, 2008
First Posted
September 3, 2008
Study Start
September 1, 2008
Primary Completion
September 1, 2009
Study Completion
September 1, 2009
Last Updated
March 6, 2025
Results First Posted
June 13, 2014
Record last verified: 2025-02